Higher dose of common drug may raise hospital risk for seniors with kidney trouble
NCT ID NCT07382960
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This completed study looked at 1,100 older adults (65+) with advanced chronic kidney disease who started taking pramipexole, a drug for restless legs or Parkinson's. Researchers compared a very low starting dose (0.125 mg/day) to slightly higher doses (0.25 or 0.375 mg/day) to see if the higher doses increased the risk of hospitalization, emergency visits, or death within 30 days. The goal is to find safer prescribing practices for this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pramipexole
- What this could lead to
- If successful, this study could help doctors choose safer starting doses of pramipexole for older adults with kidney disease, reducing hospital visits.
- What could go wrong
- This is an observational study, not a controlled trial, so it can only show links, not cause and effect. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
1,100 people
The number who actually took part.
- Started
-
Jan 2008
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Older adults aged 66 years or older with advanced CKD (eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled at least one outpatient prescription for oral pramipexole between 2008 and 2024 in Ontario.
- Ages
-
66 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The cohort will include older adults aged 66 years or older with advanced CKD (an eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for pramipexole at an outpatient pharmacy under the Ontario Drug Benefit (ODB) program from January 1, 2008, to December 01, 2024. The age criterion is set to guarantee that individuals in this population have had at least one year of prior prescription drug coverage. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. Exclusion Criteria: 1. Data cleaning exclusions (e.g., individuals with missing or invalid age or sex or administrative database number, OHIP ineligible on index date, death on or before the index date, non-Ontario residents). The investigators anticipate that very few records will be excluded due to data cleaning. 2. To ensure that patients are new pramipexole users, the investigators will exclude those with any evidence of pramipexole use in the 180 days before the index date. 3. Patients with more than one study drug prescription on the index date will be excluded, as this complicates the ability to ascertain the prescribed dose accurately. 4. The investigators will exclude patients with a prescription of dopamine agonists and non-oral study drugs in the previous 180 days, including the index date. 5. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date. 6. Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription. 7. Patients with no outpatient serum creatinine measurement 0- 365 days before the index date will be excluded. 8. Patients with unstable baseline kidney function (If the most recent serum creatinine test before the index date was an inpatient test \[ER or hospitalization\], and there is not at least one 'outpatient' serum creatinine in the year before test date 1) (If the most recent prior serum creatinine test before the index date was an inpatient test \[ER or hospitalization\], and while there is at least 'outpatient' serum creatinine test in the year before, the most recent outpatient test before differs by an eGFR 10 mL/min/1.73 m2 or more from the value on ) will be excluded. In Ontario, it has been shown that outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values. 9. The investigators will exclude patients receiving pramipexole doses other than 0.125, 0.25, or 0.375 mg/day. 10. If more than one eligible prescription is available, restrict it to the first. The date of this prescription will be the index date.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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London Health Sciences Centre Research Institute
London, Ontario, Canada
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Other studies related to the condition(s) this trial covers.
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